The Vega™ SPAN™ Spinous Process Plate System is a posterior non-pedicle supplemental fixation system intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion for the following indications: spondylolisthesis, trauma (fracture or dislocation), tumor, or degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies). The device is intended for use with bone graft material and is not intended for stand-alone use.

Device Description

The Vega™ SPAN™ Spinous Process Plate System consists of plates of varying length and hub diameters, set screws, and instruments required for implantation. Spikes are present on the sides of the plate that interface with the spinous process to restrain the plate from rotating post-operatively. The device is offered with varying lengths and hub diameters to accommodate anatomical needs. Set screws are used to secure the two sides of the device into the final compressed and implanted construct. System components are supplied non-sterile, are single use and are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136.

AI/ML Overview

The provided text describes the regulatory clearance for the Vega™ SPAN™ Spinous Process Plate System, not an AI/ML powered medical device. Therefore, the information requested about acceptance criteria and studies related to AI/ML device performance (such as sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment) is not applicable or available in the given document.

The document focuses on demonstrating substantial equivalence to predicate devices through a 510(k) submission, primarily relying on mechanical testing and comparison of technological characteristics.

Here's the relevant information based on the provided text, aligned with the spirit of your request regarding device performance and acceptance:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Demonstration of Equivalence)	Reported Device Performance (Method Used)
Equivalence in Indications for Use	Compared to predicate devices (K073278, K071877, K050675)
Equivalence in Function	Compared to predicate devices
Equivalence in Operating Principles	Compared to predicate devices
Equivalence in Materials (Titanium alloy (Ti-6AL-4V ELI) conforming to ASTM F 136)	System components are fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F 136.
Performance in Static Compression	Mechanical testing per ASTM F1717
Performance in Dynamic Compression	Mechanical testing per ASTM F1717
Performance in Torsion	Mechanical testing per ASTM F1717

2. Sample size used for the test set and the data provenance:

Not Applicable. This device’s clearance was based on mechanical testing, not a test set of data with human subjects or images requiring "data provenance" in the context of an AI/ML device. The "test set" here refers to the physical devices undergoing mechanical tests. The specific number of devices tested is not detailed in this summary, but mechanical testing typically involves a statistically significant number of samples to demonstrate consistency.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. Ground truth, in the context of AI/ML, refers to clinically validated diagnoses or classifications. For this device, "ground truth" relates to the performance standards defined by ASTM F1717 for mechanical properties, which are established engineering standards, not expert clinical consensus.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not Applicable. Adjudication methods are used to establish ground truth in studies involving human interpretation or clinical outcomes. This study involved mechanical testing against established standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. An MRMC study was not conducted as this is a physical medical device, not an AI/ML diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable. This is not an algorithm-only device. The "standalone" performance here refers to the device's mechanical integrity as tested in a laboratory setting. The results of these tests demonstrated the device meets mechanical performance criteria as defined by ASTM F1717.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the mechanical testing, the "ground truth" was established engineering standards, specifically ASTM F1717, which define acceptable static and dynamic compression and torsion performance for spinal implant devices.

8. The sample size for the training set:

Not Applicable. This is not an AI/ML device, so there is no concept of a "training set" in the machine learning sense.

9. How the ground truth for the training set was established:

Not Applicable. As above, no training set was used.

Summary

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000018

1 2010

SEP

5.0 510(k) Summary

1. Sponsor

SpineFrontier. Inc. 500 Cummings Center Suite 3500 Beverly, MA 01915

Primary Contact:	John Sullivan
Telephone:	1- 978-232-3990

Date Prepared: December 7, 2009

2. Device Name and Classification:

Vega™ SPAN™ Spinous Process Plate System Proprietary Names:

Common/Usual Name: Interlaminal Spinal Fixation Orthosis

Classification Name: Interlaminal Spinal Fixation Orthosis (21 CFR 888.3050), Class II

Product Code: KWP

3. Predicate Devices

K073278 - Nuvasive Spinous Process Plate System K071877 - Lanx Spinal Fixation System K050675 - DePuy Expedium Spinous Process Plates

4. Device Description

System components are supplied non-sterile, are single use and are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136.

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5. Intended Use

The Vega™ SPAN™ Spinous Process Plate System is a posterior nonpedicle supplemental fixation system intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion for the following indications: spondylolisthesis, trauma (fracture or dislocation), tumor, or degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies). The device is intended for use with bone graft material and is not intended for stand-alone use.

6. Technological Characteristics & Substantial Equivalence Determination

The SpineFrontier Vega™ SPAN™ Spinous Process Plate System was shown to be substantially equivalent to predicate devices through comparison of indications for use, function, operating principles, and materials.

The Vega™ SPAN™ Spinous Process Plate System has been shown to be substantially equivalent to predicate devices in terms of performance (mechanical testing). Clinical data was not required for this device.

Mechanical testing included performance assessments of static and dynamic compression and torsion per methods described in ASTM F1717.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

SpineFrontier, Inc. % Mr. John Sullivan Director of QA and Regulatory Compliance 500 Cummings Center, Suite 3500 Beverly, Masschusetts 01915

SEI-1 2010

K102020 Re:

Trade Name: Vega™ SPAN™ Spinous Process Plate System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP Dated: July 6, 2010 Received: July 19, 2010

Dear Mr. Sullivan,

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 - Mr. John Sullivan

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Nubare Buchup

Mark N. Melk Director Division of Surgical. Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K102020 000017

Indications for Use Statement

510(k) Number (if Known): K102020

Indications For Use:

Prescription Use: X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use: (Part 21 CFR 807 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number______________

4.0

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.